Risk of spontaneous abortion and other pregnancy outcomes in 15-25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom
Risk of spontaneous abortion and other pregnancy outcomes in 15-25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom
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DOI：
10.1016/j.vaccine.2015.07.024
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发表时间：
2015-11-27
期刊：
影响因子：
5.5
通讯作者：
Chambers, Christina D.
中科院分区：
文献类型：
--
作者：
Baril, Laurence;Rosillon, Dominique;Chambers, Christina D.
背景资料：我们采用观察性队列设计评估了妊娠期意外暴露于HPV-16/18疫苗后自然流产（SA）的风险。方法：研究人群包括在英国（UK）临床实践研究Datalink全科医学在线数据库中注册的15-25岁女性，在2008年9月1日至2011年6月30日期间接受过至少一剂HPV-16/18疫苗。暴露妇女的妊娠第一天在任何HPV-16/18疫苗剂量前30天至45天（延长暴露期为90天）之间。未接触的妇女怀孕第一天为末次给药后120天至18个月。结果：207例暴露者中SA发生率为11.6%，632例非暴露者中SA发生率为9.0%，经孕龄校正后的女性风险比（HR）为1.30（95%可信区间：0.79-2.12）。根据给药次数（-30至+4-5天风险期）进行的敏感性分析显示，在风险期内接受1次给药的18/178名女性的SA HR为1.11（0.64-1.91），而在4-5周内接受2次给药的6/29名女性的SA HR为2.55（1.09-5.93）。早产/足月/过期分娩、小于胎龄儿/大于胎龄儿和出生缺陷的比例在接触和未接触的妇女之间没有显著差异。结果是一致的使用（美国）SA定义的胎儿损失之间的第1-19周和/或延长的risk periods.Conclusion：有没有证据表明SA和其他不良妊娠结局的风险增加，在年轻女性无意中HPV-16/18-妊娠接种疫苗。然而，建议怀孕或试图怀孕的妇女推迟接种疫苗，直到怀孕结束。(C)2015作者由Elsevier Ltd.发布。这是CC BY-NC-ND许可下的开放获取文章。
Background: We assessed the risk of spontaneous abortion (SA) after inadvertent exposure to HPV-16/18-vaccine during pregnancy using an observational cohort design.Methods: The study population included women aged 15-25 years registered with the Clinical Practice Research Datalink General Practice OnLine Database in the United Kingdom (UK), who received at least one HPV-16/18-vaccine dose between 1st September 2008 and 30th June 2011. Exposed women had the first day of gestation between 30 days before and 45 days (90 days for the extended exposure period) after any HPV-16/18-vaccine dose. Non-exposed women had the first day of gestation 120 days-18 months after the last dose. SA defined as foetal loss between weeks 1 and 23 of gestation (UK definition).Results: The frequency of SA was 11.6% (among 207 exposed) and 9.0% (632 non-exposed), women: hazard ratio (HR) adjusted for age at first day of gestation 1.30 (95% confidence interval: 0.79-2.12). Sensitivity analysis per number of doses administered (-30 to +45-day risk period) showed a HR for SA of 1.11 (0.64-1.91) for 18/178 women with one dose during the risk period versus 2.55 (1.09-5.93) in 6/29 women with two doses within a 4-5 weeks period. The proportion of pre-term/full-term/postterm deliveries, small/large for gestational age infants, and birth defects was not significantly different between exposed and non-exposed women. Results were consistent using a (United States) SA definition of foetal loss between weeks 1-19 and/or the extended risk period.Conclusion: There was no evidence of an increased risk of SA and other adverse pregnancy outcomes in young women inadvertently HPV-16/18-vaccinated around gestation. Nevertheless, women who are pregnant or trying to become pregnant are advised to postpone vaccination until completion of pregnancy. (C) 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license.